MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2012-04-20 for VANGUARD UNV 5IN1 TIBIAL TRIAL 71/75X10 N/A 32-483840 manufactured by Biomet Orthopedics.
[2601616]
It was reported that patient underwent total knee arthroplasty on (b)(6) 2012. During the procedure, as the surgeon was trying to insert the tibial bearing trial, the bearing fractured. The fractured piece was removed from the patient's wound and the procedure was completed without significant delay.
Patient Sequence No: 1, Text Type: D, B5
[9813616]
Review of returned device shows that bearing trial exhibits both indentations and a fracture, but it is unknown if the indentations and fracture occurred at the same time. It is conceivable that user techniques and tool impact forces that created the indentations could have eventually contributed to the fracture. There are strong visual signs that the trial bearing was forced into spaces between the femoral and tibial tray that were too narrow to accommodate it.
Patient Sequence No: 1, Text Type: N, H10
[9819988]
The user facility is outside of the united states. No medwatch report was received. Current information is insufficient to permit a conclusion as to the cause of the event. Review of device history records show that lot released with no recorded anomaly or deviation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2012-00496 |
| MDR Report Key | 2543522 |
| Report Source | 01,07 |
| Date Received | 2012-04-20 |
| Date of Report | 2012-03-21 |
| Date of Event | 2012-03-21 |
| Date Mfgr Received | 2012-03-21 |
| Device Manufacturer Date | 2008-04-02 |
| Date Added to Maude | 2012-04-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. ANGELA DICKSON |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5743711021 |
| Manufacturer G1 | BIOMET ORTHOPEDICS |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VANGUARD UNV 5IN1 TIBIAL TRIAL 71/75X10 |
| Generic Name | TEMPLATE |
| Product Code | IQO |
| Date Received | 2012-04-20 |
| Returned To Mfg | 2012-06-06 |
| Model Number | N/A |
| Catalog Number | 32-483840 |
| Lot Number | 924740 |
| ID Number | N/A |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET ORTHOPEDICS |
| Manufacturer Address | 56 E. BELL DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2012-04-20 |